10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINI-DOPPLER ES-100
FDA 510(k)
FDA Class 2
·Cardiovascular
HomeSafe (Landline) Home Communicator
FDA UDI
Lifeline Systems Company·00884838071681·7000L Home Communicator
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE FEMORAL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code HWA·August 18, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 30, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 20, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 11, 2015
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018